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Epirubicin Effective But Toxicity Is Increased

Epirubicin Effective But Toxicity Is Increased

June 01, 1995

LOS ANGELES--In a Canadian study of women with node-positive adenocarcinoma
of the breast, a chemotherapy regimen (CEF) including epidoxorubicin
(Epirubicin), an anthracycline available in Canada and Europe,
produced better results than standard CMF (cyclophosphamide, methotrexate,
and fluorouracil), Dr. Mark Levine reported at the ASCO annual
meeting.

The beneficial effects of CEF (improved relapse-free survival
and a lower risk of recurrence) came at a cost of more acute toxicity
and worse quality of life during the first month of treatment.

Dr. Levine said that dose escalation of doxorubicin (Adriamycin)
is limited by the potential for cardiotoxicity. Since Epirubicin
has comparable antitumor activity but is less cardiotoxic, it
was included in the experimental regimen with an eye toward increasing
the dose intensity of the anthracycline component.

Speaking on behalf of the National Cancer Institute of Canada
Clinical Trials Group, Dr. Levine reported that the 716 pre- or
perimenopausal women in the trial were randomized to receive CMF
or CEF after mastectomy or lump-ectomy and axillary dissection.
Both regimens were given monthly for 6 months.

CEF consisted of cyclophosphamide, 75 mg/m² orally on days
1 through 14; epidoxorubicin, 60 mg/m² IV on days 1 and 8;
and fluorouracil, 500 mg/m² IV on days 1 and 8. These patients
also received clotrimoxazole prophylaxis.

Better Relapse-Free Survival

Significantly more patients treated with CEF than CMF were alive
and relapse free at 3 years (about 70% vs 60%), Dr. Levine said.
At a median follow-up of 33 months, breast cancer had recurred
in 35% of the CMF group, compared with 27% of the CEF group. Cox
analysis showed that the risk of recurrence was 27% lower in CEF
than in CMF patients.